Clinical Trials

Cancer Type: Breast


1999-225

Title: Pilot Study For Analysis Of Tumor Gene Expression By DNA Microarray Analysis In Patients Undergoing Breast Cancer Surgery Or Core Biopsy Sampling.

Description: This study is for patients who are going to have surgery for breast cancer. The purpose of this study is to refine a technique that identifies differences in gene expression between breast tissue in different patients and to evaluate the ability of reflectance confocal microscopy to assess the adequacy and content of biopsy specimens immediately after they are collected. This information is important to better understand the diagnosis and treatment of breast cancer.

Patients who participate in this study will have several small pieces of tissue taken at the time of surgery for use in research tests.

Forms:

Contact: Ann Gallagher
Email: ALG@georgetown.edu
Phone: 202-687-7606

2010-146

Title: I-SPY 2 TRIAL: Investigation of Serial studies to Predict Your Therapeutic Response with Imaging and Molecular Analysis 2.

Description: This study is for women with newly diagnosed breast cancer who will receive chemotherapy prior to surgery (neoadjuvant therapy). There are 2 phases of this study: the screening phase and the treatment phase. The screening phase is to determine whether women are eligible to participate in the treatment phase. The purpose of the treatment phase is to try to determine how women with breast cancer will respond to standard chemotherapy and standard chemotherapy with investigational drugs on the basis of particular markers in the tumor tissue and blood. In addition to treatment all subjects on this study will be required to undergo 2 core biopsies of their tumor and have 3 breast MRIs for research purposes and have blood drawn for research studies. The standard chemotherapy in this trial is 12 weeks of paclitaxel followed by 4 cycles of doxorubicin and cyclophosphamide given once every 2 or 3 weeks. Subjects with HER2+ breast cancer will also receive trastuzumab during the 12 weeks of paclitaxel. Subjects will be randomized (like the flip of a coin) to either standard treatment or standard treatment plus an investigational (not yet approved by the FDA) drug. Which investigational drug one will receive will be based on when a subject enters the study and which drugs are being tested at that time.

Forms:

Contact: Julie Castle 
Email: bickmorj@georgetown.edu
Phone: 202-687-2209

2010-535 

Title: A Phase I/II Trial of TKI258 (Dovitinib) in Combination with an Aromatase Inhibitor in Patients with Metastatic Breast Cancer.

Description: This study is for women with confirmed hormone receptor positive Her-2 negative advanced breast cancer with evidence of disease resistance to an aromatase inhibitor. The purpose of this study is to determine the effects (good and bad) of dovitinib in combination with anastrozole (1 mg daily), exemestane (25 mg daily) or letrozole (2.5 mg daily) in patients with hormone-receptor positive metastatic breast cancer whose cancer is getting worse while on initial treatment. This research is being done to find a safe dose of the combination of study drugs and to determine the potential side effects of the study drugs when given together. Depending on the side effects, not all subjects will receive the same dose of dovitinib. Potential patients may have received unlimited prior hormonal therapy, but must have had their disease worsen while receiving an aromatase inhibitor in the metastatic setting or within 6 months of completing adjuvant therapy with an aromatase inhibitor. Both Dovitinib and the aromatase inhibitors used in this study are pills that will be taken at home.

Hospitals Offering This Trial: Lombardi/MedStar Georgetown University Hospital; Franklin Square Hospital Center; Washington Hospital Center

Forms:

Contact:
Email: Noviella@georgetown.edu, bickmorj@georgetown.edu
Phone: 202-784-0038, 202- 687-2209

2011-001 

Title: CALGB 70806: Vitamin D and Breast Cancer Biomarkers.

Description: This study is for premenopausal women whose mammogram shows increased breast density of 25% or greater. The purpose of this study is compare the effects of taking vitamin D supplements everyday for 1 year with those of taking placebo (sugar pills) every day for 1 year on several biomarkers of breast cancer risk. Biomarkers of breast cancer risk are substances found in blood and cells known to be associated with risk for breast cancer. In this study we will look at 3 biomarkers: breast density, insulin-like growth factor 1, and breast cell changes, to see how they respond to vitamin D or placebo. We are testing the effects of vitamin D on these because some research studies show that vitamin D may protect against breast cancer. Subjects on this study will have needle biopsies of their breast, a blood draw, and will be asked to complete some questionnaires before taking vitamin D or placebo and after one year.

Forms:

Contact: Hussein Zughaib
Email: hz124@georgetow.edu
Phone: 202-687-3091

2011-156

Title: SCUSF 0806: Phase II placebo-controlled trial of lisinopril and Coreg CR to reduce cardiotoxicity in patients with breast cancer receiving (neo)adjuvant chemotherapy with trastuzumab (Herceptin).

Description: This study is for patients who have been diagnosed with breast cancer and are scheduled to start trastuzumab (Herceptin), which can cause problems with heart function. The purpose of this study is to compare the effects, good and/or bad, of an ACE inhibitor (lisinopril) or a beta-blocker (Coreg CR {carvedilol phosphate extended release]) on heart function during treatment with trastuzumab (Herceptin), a drug given as treatment for your breast cancer. Lisinopril and Coreg CR are used to treat high blood pressure, heart failure, and in heart attack patients. Study doctors want to find out which treatment (lisinopril or Coreg CR) is better at protecting heart function during treatment of breast cancer. The effect of the medicines will be compared to a placebo, which contains no active frug. All subjects will only get one of the study medicines (lisinopril, Coreg CR or placebo). The study medicine is given as a pill once a day.

Hospitals Offering This Trial: Lombardi/MedStar Georgetown University Hospital; Washington Hospital Center

Forms:

Contact: Nellie Novielli or Julie Castle
Email: NOVIELLA@georgetown.edu, BICKMORJ@georgetown.edu
Phone: 202-784-3923 or 202-687-2209

2013-025

Title: Randomized Double-Blind Placebo Controlled Study of Subcutaneous Testosterone in the Adjuvant Treatment of Postmenopausal Women with Aromatase Inhibitor Induced Arthralgias

Description: The purpose of this study is to compare the effects, good and/or bad, of the study agent, testosterone, with a placebo (an inactive agent) on joint pain caused by taking aromatase inhibitors. The testosterone will be mixed with a little anastrozole to prevent any medication from turning into estrogen. The testosterone/placebo is a pellet that is placed just under your skin on the upper buttocks or lower abdomen. Our study team member will surgically place the pellet. In this study, you will receive either the testosterone or placebo. You will not receive both.

Forms:

2013-0278

Title: SAFE-HEaRt: A Pilot Study Assessing the Cardiac SAFEty of HER2 Targeted Therapy in Patients with HER2 Positive Breast Cancer and Reduced Left Ventricular Function.

Description: To evaluate the cardiac safety of HER2 targeted therapy (non-lapatinib) in patients with HER2 positive breast cancer and reduced left ventricular ejection fraction (LVEF) when given concomitantly with cardiac treatment.

Hospitals Offering This Trial: Lombardi/MedStar Georgetown University Hospital; Washington Hospital Center

Forms:

Contact: Antonella Novielli/ Julie Castle
Email: noviella@georgetown.edu, bickmorj@georgetown.edu
Phone: 202-784-3923/202-687-2209

2013-0364

Title: SWOG S1207: Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating The Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk, Hormone Receptor-Positive and HER2/Neu Negative Breast Cancer.

Description: The purpose of this study is to see whether treatment with everolimus plus hormone treatment after chemotherapy will increase the time without your cancer returning. The current standard treatment after chemotherapy is hormone treatment alone. Everolimus is a drug currently approved for the treatment of patients with advanced or metastatic kidney cancer. It is considered investigational for breast cancer patients. In this study, you will get hormone treatment with either everolimus or with placebo (a pill with no medication). The combination of hormonetreatment and everolimus is experimental in patients with breast cancer.

Hospitals Offering This Trial: Lombardi/MedStar Georgetown University Hospital; Franklin Square Hospital Center; Union Memorial Hospital; Washington Hospital Center

Forms:

Contact: Nellie Novielli; Julie Castle
Email: noviella@georgetown.edu; bickmorj@georgetown.edu
Phone: 202-784-3923; 202-687-2209

2013-0381

Title: Pilot Study to Evaluate Conditionally Reprogrammed Cells from Unresected Estrogen Receptor Positive Breast Tumors Treated with Endocrine Therapy Alone.

Description: You are being asked to participate in this study because the biopsies of your breast tumor may help investigators develop new tools for selecting the right therapy for each breast cancer patient. Breast cancer is an overgrowth of abnormal cells in the breast that can eventually spread to the other organs, if left untreated. Similarly to each person being different from another, also each breast cancer is different from one patient to another. Yet, currently most breast cancers are treated with the same combination of medications. Sometimes a medication that works for one patient, does not work for another due to the fact that her breast cancer is different. The breast cancer cells collected from the biopsies will be grown on a dish and drugs will be tested on the cells, instead of testing the drugs on patients.

Forms:

2013-0618

Title: A Randomized, Multicenter, Double -Blind Phase 3 Study Of PD-0332991 Plus Letrozole Vs Placebo Plus Letrozole In Postmenopausal Women Weith ER (+), HER2 (-) Breast Cancer who have not received any prio systemic anti-cancer treatment for advanced disease.

Description: The purpose of this research study is to compare the effects of the study drug, PD-0332991 in combination with letrozole, with placebo in combination with letrozole to find out which is better for treating advanced breast cancer.

  • PD-0332991 is a new investigational drug. A new investigational drug is one that is currently not approved for sale in this country.
  • A placebo looks like the study drug but does not contain any drug. Researchers use a placebo to see if the study drug works better or is safer than not taking anything.
  • Letrozole is a drug that is approved for the treatment of advanced breast cancer that is sensitive to hormonal treatment. You do not have to participate in this study to receive letrozole. Letrozole is available outside of this research study by a doctor's prescription.

PD-0332991, letrozole and placebo are taken by mouth.

Subjects will be randomized into one of two treatment regimens.

  1. PD-0332991 plus Letrozole OR
  2. Placebo Plus Letrozole.

Forms:

2013-0962

Title: A Pilot Study to Evaluate Conditionally Reprogrammed Cells from Triple Negative Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy.

Description: Breast cancer research led to improved treatments. However, not all breast cancers can be currently cured. Cancers that may seem very similar to each other can behave very differently. An example of such cancer is triple negative breast cancer, a subtype that is only sensitive to chemotherapy. Some triple negative breast cancers are cured with chemotherapy, while others are not sensitive to the drugs that we currently use. However, we do not know how to distinguish them from each other and women with this type of cancer receive the same type of treatments, which may or not be effective. Therefore, we need to understand how we can predict which tumors will do well with the available drugs and develop better drugs for those that do not.

This study aims to test a new promising technique that allows growing cancer cells from a patient in the laboratory. If the technique works well in breast cancer, these cells could then be studied and new treatments could be tested. The knowledge obtained this way could have a significant impact in the development of breast cancer treatments, particularly for tumors like triple negative breast cancer that currently have limited treatment options.

Forms:

2013-1173

Title: ECOG E2108: A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer.

Description: The standard treatment for metastatic breast cancer is the use of chemotherapy, anti-hormone pills, or other medication. When the cancer is no longer only in the breast and has spread to other areas of the body, surgery and/or radiation for the tumor in the breast cannot control the other areas of the cancer and are only used if the breast tumor is causing skin breakdown or pain, which happens only in some patients. For most people, the tumor in the breast is controlled with medicine and does not cause problems. We do not know if local treatment (surgery and/or radiation) used early in the course of treatment of the breast cancer will help patients with metastatic breast cancer live longer or not. The purpose of this study is to compare the good and bad effects of a new approach that includes surgery plus radiation for the tumor in your breast to the standard approach of continued treatment with the medication which is working to control your tumor. In this study, you will get either surgery plus radiation for your breast, or continue with the best medical treatment advised by your doctor. If you receive the standard treatment but the medicine is no longer controlling the tumor in the breast, and your doctor feels you need surgery or radiation, you may receive this when you need it.

Forms:

2013-1226

Title: KAITLIN: A Randomized, Multicenter, Open-Label, Phase III Trial Comparing Trastuzumab Plus Pertuzumab Plus a Taxane Following Anthracyclines versus Trastuzumab Emtansine Plus Pertuzumab Following Anthracyclines as Adjuvant Therapy in Patients with Operable HER2-Po.

Description: This two-arm, randomized, open-label, multicenter study will evaluate the efficacy and safety of Kadcyla (trastuzumab emtansine, also known as T-DM1) in combination with Perjeta (pertuzumab) versus Herceptin (trastuzumab) in combination with Perjeta and a taxane as adjuvant therapy in patients with HER2-positive primary invasive breast cancer. Following surgery and anthracycline-based chemotherapy, patients will receive either Kadcyla 3.6 mg/kg and Perjeta 420 mg intravenously (iv) every three weeks or Herceptin 6 mg/kg iv every three weeks in combination with Perjeta and a taxane. Anticipated time on HER2 targeted study treatment is up to 1 year.

Forms:

2013-1362

Title: OSU 13117: A single arm, phase II study of single agent trametinib followed by trametinib in combination with GSK2141795 in patients with advanced triple negative breast cancer.

Description: This study is for patients who have a partial or complete response to treatment with trametinib in advanced triple negative breast cancer (TNBC) patients. This is an open label, two-stage phase II study of single agent trametinib followed by trametinib in combination with GSK2141795 in patients with advanced TNBC.

Your body has proteins that are involved in a cancer's ability to grow and survive. Trametinib and GSK2141795 may prevent these proteins from causing cancer growth.

There are 2 parts to this study. In Part 1 of this study, you will receive trametinib. At a time in which trametinib is not working you will begin on Part 2 of the study. In Part 2 of this study, you will receive trametinib and GSK2141795.

Forms:

Pro-526

Title: CALGB 40903: Phase II Study of Neoadjuvant Letrozole for Postmenopausal Women with Estrogen Receptor Positive Ductal Carcinoma In Situ (DCIS).

Description: This study is for postmenopausal women who have ductal carcinoma in situ (DCIS), an early change in the breast that could become breast cancer in the future.

Standard treatment for DCIS includes surgery to remove the DCIS cells from the breast, or surgery followed by radiation therapy. The purpose of this study is to test whether neoadjuvant (neoadjuvant means given before surgery) treatment with the aromatase inhibitor (anti-hormonal medication) letrozole has an effect on the DCIS.

Mammograms are the standard method of detecting and measuring DCIS. The researchers conducting this study would also like to learn more about whether Magnetic Resonance Imaging (MRI) may be better for evaluating and measuring DCIS, compared to mammograms.

Subjects on this study will take letrozole as a pill once a day for up to 6 months and have an MRI for research purposes after 3 months and 6 months of treatment before surgery.

Forms:

Pro-465

Title: NSABP B-47: A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of Docetaxel Plus Cyclophosphamide or Four Cycles of Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel) to Chemotherapy Plus Traztuzumab in

Description: This is a clinical trial, which is a type of research study. You are being asked to take part in this study because you have early stage breast cancer that has been removed by surgery. Your doctor has told you that chemotherapy and other therapy after surgery will lower the chance of your cancer returning. Your breast tumor has already been tested to find out if there are too many copies of the HER2 gene in the tumor cells or too much HER2 protein on the surface of the tumor cells. When there are too many copies of the HER2 gene or too much HER2 protein, the breast cancer is called "HER2-positive". Test results have shown that your breast cancer tumor is not HER2-positive, which means that your tumor cells have a low HER2 level. In this consent form, a low level of HER2 will be called "HER2-low". This study is only for women with HER2-low breast cancer.

Forms:

2013-0587

Title: NSABP B-51/RTOG 1304: A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy.

Description: This randomized phase III trial studies standard or comprehensive radiation therapy in treating patients with early-stage breast cancer who have undergone surgery. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether comprehensive radiation therapy is more effective than standard radiation therapy in treating patients with breast cancer

Forms:

2014-0367

Title: A011202: A Randomized Phase III Trial Evaluating the Role of Axillary Lymph Node Dissection in Breast Cancer Patients (cT1-3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy.

Description: This randomized phase III trial studies axillary lymph node dissection to see how well it works compared to axillary radiation therapy alone in treating patients with node-positive breast cancer previously treated with neoadjuvant chemotherapy followed by surgery. Lymph node dissection may remove cancer cells that have spread to nearby lymph nodes in patients with breast cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. This study will evaluate whether radiation therapy is as effective as lymph node dissection.

Forms:

2014-0505

Title: NSABP B-52: A Randomized Phase III Trial Evaluating Pathologic Complete Response Rates in Patients with Hormone Receptor-Positive, HER2-Positive, Large Operable and Locally Advanced Breast Cancer Treated with Neoadjuvant Therapy of Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab (TCHP)With or Without Estrogen Deprivation or Testing the addition of hormonal therapy to usual chemotherapy in advanced breast cancer.

Description: This randomized phase III trial studies docetaxel, carboplatin, trastuzumab, and pertuzumab with estrogen deprivation to see how they work compared to docetaxel, carboplatin, trastuzumab, and pertuzumab without estrogen deprivation in treating patients with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-positive, operable or locally advanced breast cancer. Drugs used in chemotherapy, such as docetaxel, carboplatin, trastuzumab, and pertuzumab, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Estrogen can cause the growth of breast cancer cells. Hormone therapy using goserelin acetate and aromatase inhibition therapy may fight breast cancer by blocking the use of estrogen by the tumor cells. Radiation therapy uses high energy x rays to kill tumor cells. Giving combination chemotherapy and radiation therapy with or without hormone therapy may be an effective treatment for hormone receptor-positive, HER2-positive, operable or locally advanced breast cancer.

Forms: